Announced details
First-line treatment of previously untreated locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
In the Phase III REZILIENT3 trial, the combination arm extended progression-free survival compared with the chemotherapy-alone arm and met the primary endpoint (the duration of the extension and effect size are Not disclosed).
Taiho Pharmaceutical is the company's wholly owned subsidiary. Zipalertinib is being developed by Taiho Pharmaceutical and its subsidiary Taiho Oncology, Inc., in collaboration with Cullinan Therapeutics, Inc. in the United States.
The U.S. Food and Drug Administration is the U.S. drug regulatory authority. Other than the fact that Cullinan Therapeutics, Inc. is collaborating on development in the United States, its location, representative, business activities and other details are Not disclosed.
Taiho Pharmaceutical Co., Ltd.: Chiyoda-ku, Tokyo
No change to the consolidated earnings forecast for the fiscal year ending December 2026
The company does not address Contract Value / Offering price.
Phase III REZILIENT3 trial; Burnett et al. (PLOS ONE, 2021); Riess et al. (Journal of Thoracic Oncology, 2018)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Zipalertinib (development code: CLN-081/TAS6417) plus platinum-based chemotherapy |
| Counterparty | U.S. Food and Drug Administration (FDA) / Cullinan Therapeutics, Inc. |
| Counterparty overview | The U.S. Food and Drug Administration is the U.S. drug regulatory authority. Other than the fact that Cullinan Therapeutics, Inc. is collaborating on development in the United States, its location, representative, business activities and other details are Not disclosed. |
| Relationship with the Company | Taiho Pharmaceutical is the company's wholly owned subsidiary. Zipalertinib is being developed by Taiho Pharmaceutical and its subsidiary Taiho Oncology, Inc., in collaboration with Cullinan Therapeutics, Inc. in the United States. |
| Launch date | NDA submission is scheduled to be completed by the end of 2026 |
| Applicable area | First-line treatment of previously untreated locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations |
| Location | Taiho Pharmaceutical Co., Ltd.: Chiyoda-ku, Tokyo |
| Quantitative Effects | In the Phase III REZILIENT3 trial, the combination arm extended progression-free survival compared with the chemotherapy-alone arm and met the primary endpoint (the duration of the extension and effect size are Not disclosed). |
| Impact on Business Performance | No change to the consolidated earnings forecast for the fiscal year ending December 2026 |
| Source | Phase III REZILIENT3 trial; Burnett et al. (PLOS ONE, 2021); Riess et al. (Journal of Thoracic Oncology, 2018) |
Items this document does not state (8)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because the planned interim analysis of the Phase III REZILIENT3 trial showed a statistically significant and clinically meaningful extension of progression-free survival in the combination arm compared with the chemotherapy-alone arm, thereby meeting the primary endpoint.